FDA Announces it will Start Regulating Medical Laboratory Testing

Whether a patient is simply finding out whether or not she’s pregnant, or is undergoing serious life-or-death surgery, lab tests are a large part of the hospital experience. If something goes wrong with those lab tests the result can be a delayed diagnosis which in the worst cases, can result in a wrongful death. While one might assume that the Food and Drug Administration (FDA) already regulated these tests, that is not the case for all tests. However, that is about to change.

New Process

The New York Times reports that the FDA announced on Thursday that it will start regulating medical laboratory testing. This move has been opposed by both some laboratories and some pathologists who claim that regulation is unnecessary and will hurt innovation when it comes to creating tests for rare diseases. The FDA has attempted to address these concerns by saying it will phase in the regulations of the tests over nine years. It will also focus primarily on regulating tests that pose a high level of risk to patients if the test result is incorrect.
Historically, the FDA has reviewed testing devices made by traditional manufacturers before they have gone to market, but it has not reviewed laboratory developed tests before they are used. Laboratory developed tests were generally not widely used, so they were not a high regulatory priority. However, now these laboratory developed tests are being used on a much wider scale, so the policy is changing. Under the proposed regulations, the safety and efficacy of the most risking lab developed tests will have to be proven before they go to market.

FDA Commissioner Margaret A. Hamburg, M.D. Explained the reason for the regulations, saying, “Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA…Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether.” The FDA’s press release also notes that its intention is to exercise “enforcement discretion” for laboratory developed tests for rare diseases, which should address regulation opponents’ concern over decreased innovation.

The Washington Post explains in its report on the regulations, that the FDA has chosen not to actively regulate laboratory tests for decades because the tests have always been relatively simple. However, in recent years laboratory tests have become much more widely used and specialized, especially as they are used to diagnose forms of cancer and other diseases by using complex genetic data. The report cites examples of tests that have had reliability issues in recent years, including tests for cervical cancer, Lyme disease, and whooping cough.

This move is good for patients. The tests that are going to be regulated are the tests where an inaccuracy can be most devastating. If these regulations can prevent cases of delayed diagnosis and missed diagnosis, then lives will ultimately be saved. Meanwhile the FDA seems to have found a balance to allow for the development of testing for rare conditions, so the rare patients who have those conditions should not be harmed by the regulations. Hopefully this will result in more reliable tests, and better outcomes for both the patients and the physicians treating them.

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